Cataract, Diabetic Retinopathy, Epiretinal Membrane, Healthy, Macular Holes, Ocular Tumor, Preretinal Fibrosis, Retinal Detachment, Retinal Disease, Strabismus
Conditions
Keywords
Microscope Integrated optical coherence tomography, MIOCT, OCT Angiography, OCTA
Brief summary
The overall five-year goals of the project are to develop novel technology to provide actionable new information through provision of live volumetric imaging during surgery, improving surgical practice and outcomes. The investigators believe this technology will enable novel ophthalmic and other microsurgeries not possible due to current limitations in surgical visualization.
Interventions
DEVICEMicroscope integrated optical coherence tomography
This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the patient is not disturbed by the light.
Sponsors
National Eye Institute (NEI)
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy controls: Healthy eyes without known disease: refractive error including myopia and non-significant cataract is allowed. For selected testing pseudophakia is allowed. 2. Surgeons as research subjects: Adult (≥18 years old) 3. Surgical patients (vitreoretinal surgery): Patients undergoing examination under anesthesia or surgery for vitreoretinal diseases 4. Surgical patients (anterior segment surgery-glaucoma, ocular surface or strabismus requiring extraocular muscle surgery): Include both adults and children. Patient undergoing primary, elective minimally invasive glaucoma surgery, ocular surface surgery, or strabismus surgery.
Exclusion criteria
1. Healthy controls: Any ocular disease that restricts the ability to perform OCT scanning. Conflict of interest with investigators/study personnel, e.g. a student in the lab of an investigator. 2. Surgeons as research subjects: no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal and/or corneal microscope integrated optical coherence tomography image capture | Year 1 | Ability to capture images |
| Quality of retinal and/or corneal microscope integrated optical coherence tomography image capture | Year 1 | Quality of MIOCT images scored based on standard microanatomy and ability to detect presence or absence of ocular pathologies based on review by a masked grader. |
| Retinal vascular flow on optical coherence tomography angiography (OCTA) versus fluorescein angiography | Year 1 | Cross correlation of ability to capture vessels and vessel pathology between OCTA and fluorescein angiographic images. |
| Assessment of change in pattern of ocular vascular flow before and after standard clinical surgical steps. | Year 1 | Presence or absence of change in ocular morphology in pattern of vascular flow compared to prior to surgical steps |
| Assessment of change in ocular morphology before and after standard surgical steps | Year 1 | Presence or absence of change in ocular morphology before and after standard surgical steps |
| Estimate of subretinal fluid volume before and after surgery for retinal detachment based on surgical view versus based on OCT output | Year 1 | Volume estimates from surgeons analyzed relative to the postoperative calculated volume from the intraoperative MIOCT |
Countries
United States
Contacts
Primary ContactNeeru Sarin, MBBS
Backup ContactMichelle N McCall, MCAPM, BA
Outcome results
None listed